BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Break Wave

    K Number: K261086 · Decision Apr 29, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    55
    Applicant Total
    3
    Review Days
    28

    Basic Information

    Device Name
    Break Wave
    K Number
    K261086
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5990
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sonomotion, Inc.
    Date Received
    April 1, 2026
    Decision Date
    April 29, 2026
    Product Code
    LNS
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LNS Lithotriptor, Extracorporeal Shock-Wave, Urological

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